Cleared Traditional

K833236 - TELEPHONE TRANSMITTER T-10 EEG

K833236 is an FDA 510(k) clearance for TELEPHONE TRANSMITTER T-10 EEG, manufactured by Pharmaquest Corp.. The device is a Class 2 Radiology device with product code GYE cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K833236 · Pharmaquest Corp. · Radiology device
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Nov 1983
Decision
105d
Days
Class 2
Risk

K833236 is an FDA 510(k) clearance for the TELEPHONE TRANSMITTER T-10 EEG. Classified as Encephalogram Telemetry System (product code GYE), Class II - Special Controls.

Submitted by Pharmaquest Corp. (Walker, US). The FDA issued a Cleared decision on November 29, 1983 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 882.1855 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pharmaquest Corp. devices

FDA 510(k) Submission Details - K833236

510(k) Number K833236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1983
Decision Date November 29, 1983
Days to Decision 105 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 107d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYE Device Classification - Class 2, Special Controls

Product Code GYE Encephalogram Telemetry System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1855
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - GYE Encephalogram Telemetry System

All 7
Devices cleared under the same product code (GYE) and FDA review panel - the closest regulatory comparables to K833236.
DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER
K970659 · Telediagnostic Systems, Inc. · May 1997
MODEL 219 TELEMETRY SYSTEM
K895895 · Mennen Medical, Inc. · Feb 1990
BMS-2000 MOBILE EEG SYSTEM
K891405 · Buckman Co., Inc. · Aug 1989
TELEMETRY SYSTEM XMT-1 & REC-1
K792371 · Burdick Corp. · Jan 1980
CMS 6000
K792380 · Physio-Control Corp. · Jan 1980
G.E. TELEMETRY MONITORING
K761259 · General Electric Co. · Dec 1976